After a prior rejection, Astellas can head into the weekend celebrating a class-first FDA approval for its new gastric cancer ...

Astellas Pharma today announced that the US Food and Drug Administration (FDA) has approved VYLOY (zolbetuximab-clzb) in ...

VYLOY is the first and only CLDN18.2-targeted treatment approved in the U.S. for adults with advanced gastric and gastroesophageal junction cancer whose tumors are CLDN18.2 positive TOKYO, Oct. 18 ...

Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the U.S. Food and Drug Administration (FDA) has approved VYLOY™ (zolbetuximab-clzb) in combination ...

FDA also approved the Ventana CLDN18 (43-14A) RxDx Assay, from Ventana Medical Systems, Inc. and Roche Diagnostics, to ...

The FDA approved zolbetuximab (Vyloy), a claudin 18.2 (CLDN18.2)-directed cytolytic antibody, in combination with ...

Astellas Pharma Inc. (ALPMY, ALPMY) said that the U.S. Food and Drug Administration has approved VYLOY (zolbetuximab-clzb) in ...

Zolbetuximab — now with the brand name Vyloy — is a monoclonal antibody to treat patients with advanced gastric and ...

Roche Holdings said it received Food and Drug Administration approval for its companion diagnostic of gastric and gastroesophageal junction cancer.

Roche has gained the Conformité Européenne (CE) mark of approval for its VENTANA CLDN18 (43-14A) RxDx assay to identify ...

The article, authored by a team of scientists led by Dr. Andreas Bader, Triumvira's Consulting Chief Scientific Officer, details the preclinical pharmacology and safety of TAC01-CLDN18.2 ...